Piomic Medical receives green light for U.S. pivotal trial

Piomic develops innovative medical devices for the treatment of hard-to-heal wounds. Its COMS One therapy system was awarded CE Mark Approval in May 2020. Following the approval of the U.S. Food and Drug Administration (FDA), Piomic can now launch a trial in the US too. The trial is intended to support marketing and reimbursement of COMS therapy in North America.

The U.S. Food and Drug Administration (FDA) has fully approved Piomic Medical’s Investigational Device Exemption (IDE) application for MAVERICKS, the COMS One therapy system pivotal trial in patients with therapy refractory diabetic foot ulcers. “This is another significant milestone for Piomic and a result of a multi-year R&D program that delivered comprehensive pre-/clinical data, meeting the very high standards of the U.S. FDA”, said Martin Walti, COO of Piomic Medical.  “With U.S. site selection already initiated, we look forward to enrolling the first U.S. patients early next year.”

The MAVERICKS clinical trial focuses on possible beneficial effects of COMS treatment in patients suffering from therapy-refractory diabetic foot ulcers. The prospective randomized, sham-controlled, double-blinded, pivotal clinical trial will be conducted in 224 patients at up to 20 centers throughout the United States. 

Hard-to-heal wounds pose a particular challenge for patients and therapists, but also have severe economic implications for healthcare systems, and society as a whole. Every 20 seconds, a leg of a diabetic patient is amputated, remaining the leading cause of major amputations in our modern health care system.  In the U.S. alone, it is estimated that the cost of chronic wound care ranges from 28 to 97 billion USD per year.

Piomic’s COMS One therapy system was awarded CE Mark Approval in May 2020. “Piomic is currently in the pre-revenue phase. We are bringing products into the market during an initial soft launch phase, to collect further post-market data and build a network of supporting key opinion leaders”, explained Piomic’s CEO Christopher Hertz to Startupticker.ch. Over 5,500 treatments have been performed in routine clinical practice or as part of clinical trials with more than 500 patients successfully being treated. Clinics such as the University Hospital Balgrist, University Hospital Zürich and the Hirslanden Group are actively using the system.

Piomic develops innovative medical devices for the treatment of hard-to-heal wounds, based on the proprietary COMS therapy, which incorporates the technology for concurrent optical and magnetic stimulation. COMS treatment requires minimizing training efforts and fits seamlessly into the workflow of healthcare professionals. As an adjunctive treatment, the application does not require any changes to standard of care protocols and fits well into a phase-adapted wound-healing concepts. The simplicity of use of COMS therefore allows it to be used easily across the continuum of care, from in-patient clinic to home care. Along with the possibility for self-administration, the COMS One device offers optimal conditions to enable patient self-management in a cost-effective manner.

(Press release / SK)
Picture Piomic Medcial COMS device